DARZALEX
Darzalex (daratumumab) is a CD38-directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma. It is utilized across multiple stages of the disease, including in newly diagnosed patients regardless of their eligibility for autologous stem cell transplant. The therapy is also approved for patients with relapsed or refractory disease, where it is administered as a monotherapy or in combination with various standard-of-care regimens.
How DARZALEX Works
Daratumumab is a human monoclonal antibody that binds to CD38, a glycoprotein expressed on the surface of multiple myeloma cells. Once bound, it inhibits tumor cell growth by inducing direct apoptosis and triggering immune-mediated cell lysis through complement-dependent cytotoxicity and antibody-dependent cellular phagocytosis. The drug also decreases specific subsets of immune-suppressive cells, including regulatory T cells and B cells, that express the CD38 protein.
Details
- Status
- Prescription
- First Approved
- 2015-11-16
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DARZALEX Approval History
What DARZALEX Treats
8 indicationsDARZALEX is approved for 8 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Newly diagnosed multiple myeloma in patients ineligible for autologous stem cell transplant, in combination with lenalidomide and dexamethasone
- Newly diagnosed multiple myeloma in patients ineligible for autologous stem cell transplant, in combination with bortezomib, melphalan, and prednisone
- Newly diagnosed multiple myeloma in patients eligible for autologous stem cell transplant, in combination with bortezomib, thalidomide, and dexamethasone
- Relapsed or refractory multiple myeloma in patients who have received at least one prior therapy, in combination with lenalidomide and dexamethasone
- Multiple myeloma in patients who have received at least one prior therapy, in combination with bortezomib and dexamethasone
- Relapsed or refractory multiple myeloma in patients who have received one to three prior lines of therapy, in combination with carfilzomib and dexamethasone
- Multiple myeloma in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, in combination with pomalidomide and dexamethasone
- Multiple myeloma as monotherapy in patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent
DARZALEX Target & Pathway
ProTarget
A protein highly expressed on multiple myeloma cells. Anti-CD38 antibodies target and kill myeloma cells through multiple mechanisms, becoming a backbone of myeloma treatment across disease stages.
DARZALEX Competitors
Pro2 other drugs also target CD38. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CD38). Earlier expiry dates signal biosimilar/generic opportunities.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DARZALEX FDA Label Details
ProIndications & Usage
FDA Label (PDF)DARZALEX is indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell tran...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.